All studies
Active not recruitingPHASE1, PHASE2INTERVENTIONAL

Brainshuttle AD: A Multiple Ascending Dose Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of RO7126209 Following Intravenous Infusion in Participants With Prodromal or Mild to Moderate Alzheimer's Disease

This research study, called 'Brainshuttle AD', is for people recently diagnosed with Alzheimer's disease or those showing very early signs (prodromal AD). We are investigating a new medication, RO7126209, given through a drip (intravenous infusion). The main goals are to understand if the drug is safe, how well people tolerate it, and how it moves through and affects the body. Some participants will receive the active drug, while others will receive a placebo (a dummy treatment without active medicine). This study is crucial for learning more about potential new ways to treat Alzheimer's disease.

At a glance

Status
Active not recruiting
Phase
PHASE1, PHASE2
Sponsor
Hoffmann-La Roche
Enrolment target
241
Start
15 Mar 2021
Estimated completion
30 Jun 2030

What is this study about?

This study, known as 'Brainshuttle AD', is designed to look at a new investigational drug called RO7126209. It's for people who have been diagnosed with Alzheimer's disease, either in its very early stages (sometimes called 'prodromal') or when symptoms are mild to moderate. The main purpose is to understand if this new drug is safe to use and how well people tolerate it. We also want to see how the body processes the drug and if it has any effect on the disease.

Alzheimer's disease is a condition that affects memory, thinking, and behaviour. Currently, there's no cure, but new treatments are being researched all the time. This study is an important step in that research journey, as it helps us gather early information about a potential new treatment. By understanding its safety and how it works in the body, we can decide if it should be tested in larger groups of people.

Participants will receive the drug, or a placebo, through an intravenous infusion, which means it will be given directly into a vein. This study is in 'Phase 1' and 'Phase 2', meaning it's an early look at the drug. Phase 1 studies usually focus on safety in a small group, while Phase 2 studies look at both safety and effectiveness in a slightly larger group. Your involvement can provide valuable information that could help future patients.

Key takeaways

  • This study is testing a new drug (RO7126209) for early Alzheimer's disease.
  • It aims to check the drug's safety and how the body handles it.
  • Participation involves clinic visits, scans (MRI, PET), blood tests, and a spinal tap.
  • You will receive either the active drug or a placebo.
  • A 'study partner' is required to help you throughout the study.
  • You can withdraw from the study at any time.

Who may be eligible?

To be considered for this study, you would generally need to be between 50 and 85 years old. You should have received a diagnosis of early Alzheimer's disease or be experiencing mild to moderate symptoms that are consistent with Alzheimer's. An important requirement is that a brain scan (called an amyloid PET scan) must show evidence of 'amyloid' in your brain, which is a protein linked to Alzheimer's.

You would also need to be able to understand and sign consent forms yourself. Crucially, you'd need a 'study partner' – someone who knows you well, can be in regular contact with you, and can commit to helping you throughout the study. This partner would also need to agree to take part. You should be willing to undergo various tests, including brain scans, blood tests, and a spinal tap (lumbar puncture).

There are also some other criteria, such as having a good enough memory and thinking ability to complete study assessments (even with assistance) and being able to see and hear well enough for certain tests. You also couldn't be involved in other research studies at the same time or donate blood for a period after the study.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

  1. Are you between 50 and 85 years old?
  2. Do you have a diagnosis of early, mild, or moderate Alzheimer's disease?
  3. Do you have a close friend or family member who can be your 'study partner'?
  4. Are you able and willing to have brain scans, blood tests, and a spinal tap?
  5. Do you have evidence of amyloid in your brain from a recent PET scan?
  6. Are you not currently involved in another medical research study?
Answer every question to see your result.

What does participation involve?

If you decide to participate, you will receive either the study drug RO7126209 or a placebo (an inactive substance designed to look like the drug) through an intravenous drip. You won't know which one you are receiving. The study involves regular visits to the clinic, where you will undergo various assessments. These include memory and thinking tests, magnetic resonance imaging (MRI) scans of your brain, and positron emission tomography (PET) scans to look at your brain for specific proteins related to Alzheimer's disease. You will also have blood tests and a lumbar puncture (spinal tap) to collect fluid from around your spinal cord.

Throughout the study, your health will be closely monitored, and you will have check-ups to assess your safety and how you are tolerating the treatment. You'll need to have a trusted 'study partner' who can come to appointments with you, help with assessments, and provide information about your daily life. The exact number of visits and the total duration of your participation will be explained in detail by the study team.

Potential risks and benefits

Taking part in any clinical study involves potential benefits and risks. A potential benefit of participating is receiving close medical attention and access to a promising new drug that is not yet widely available. However, there is no guarantee that the study drug will be effective for you, or that you will even receive the active drug. Potential risks could include side effects from the study drug, discomfort from procedures like blood draws, brain scans, or lumbar punctures, and the time commitment required for clinic visits. Before you decide, the study team will thoroughly explain all known risks and procedures. Remember, your participation is completely voluntary, and you have the right to withdraw from the study at any time, for any reason, without affecting your medical care.

Locations (41)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.
  • JEM Research LLC
    Verified postcode
    Atlantis, United States
  • K2 Medical Research-Winter Garden
    Verified postcode
    Clermont, United States
  • K2 Medical Research - The Villages
    Verified postcode
    Lady Lake, United States
  • K2 Medical Research, LLC
    Verified postcode
    Maitland, United States
  • Optimus U Corp
    Verified postcode
    Miami, United States
  • Charter Research - Winter Park/Orlando
    Verified postcode
    Orlando, United States
  • Advent Health Orlando
    Verified postcode
    Orlando, United States
  • Alzheimer's Research and Treatment Center
    Verified postcode
    Stuart, United States
  • Charter Research - Lady Lake/The Villages
    Verified postcode
    The Villages, United States
  • Alzheimer?s Research and Treatment Center
    Verified postcode
    Wellington, United States
  • Conquest Research, LLC
    Verified postcode
    Winter Park, United States
  • Alzheimer's Research and Treatment Center - Columbus
    Verified postcode
    Columbus, United States

Common questions

What is prodromal Alzheimer's?

Prodromal Alzheimer's means you have very early signs of the disease, like mild memory problems, but your daily life is not significantly affected yet.

What is a placebo?

A placebo is a 'dummy' treatment that looks just like the study drug but contains no active medicine. It helps researchers understand the drug's true effects.

What is an amyloid PET scan?

An amyloid PET scan is a special brain scan that can detect the presence of amyloid, a protein associated with Alzheimer's disease, in your brain.

What is a lumbar puncture?

A lumbar puncture, also called a spinal tap, is a procedure to collect a small amount of fluid from around your spinal cord for testing.

Can I continue my current Alzheimer's medication?

Yes, if you are already taking medication for Alzheimer's, you typically need to be on a stable dose for at least 8 weeks before joining the study.

How to find out more

Always speak to your GP or specialist before deciding to take part in a study.

Discussion

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